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Technical instruction
for Internal fixation Titanium Plates and Screws
1. Notes
The edition of this manual is reference to the "Detailed Rules for Production of Surgical Implants", assessed by the State Food and Drug Administration, P.R. China. Our purpose is to strengthen the quality of the medical device and related products, to provide customers with safe﹑ effective medical device, to standardize the links of the operation and use. We prepare for the manual in order to have a further communication with the production enterprises ﹑business units, medical institutions, patients and staff relevant. And also to make customers have a better understanding to our products and relevant requirements, to clear responsibilities and conditions in using process, to know the risks and the measures to reduce or prevent the risk, It is our responsibility to take care of the customers and try our best to let them satisfaction.
Relevant information and reference materials are all free distributed; we look forward to any business units and medical institutions’ specific enquiries and hope to have the opportunity to construct a business relationship with you in the future.
2. Contraindications
Such as those patients are not suitable: the older osteoporosis patients; the lack of sufficient integrity on the fracture occurs; tumors; infection; bleeding tendencies; metal allergy and those contraindicate to operation and so on.
3.Instruction for the product marking and labeling
Examples:
(1) Internal fixation Titanium Plates:
CB [1] [2] [3]-- [4]--[5] [6]
Notes:
CB – Ningbo CiBei Medical Treatment Appliance Co.,Ltd.;
[1] -- the model of the internal fixation titanium plates;
[2] -- the shape of the internal fixation titanium plates;
[3] -- thickness ;
[4] -- serial numbers ;
[5] -- exclusive code for marking (code from 001);
[6] -- material code (A stands for unalloyed titanium).
(2) Internal fixation Titanium Screws:
CB [1][2] - [3] –[4] [5]
Note:
CB –Ningbo CiBei Medical Treatment Appliance Co.,Ltd.;
[1] -- the model of the internal fixation titanium screws;
[2] -- the outside diameter of screws thread;
[3] – the length of the screws;
[4] – the code of the screws thread;
[5] -- the shape of the screws head;
4. Maintenance,Storage and Period of Validity
1, The way of transport should accord with the requirements of the order contract.
2, The storage conditions: packaged products should be placed in the place of no more than 80% relative humidity, no corrosive gases and good indoor ventilation.
3, The supplied implant products of all are sterilized by Cobalt- 60 before, which guarantee two years of validity.
4, In compliance with the proper storage conditions, counting from the date of ordering, as a result of quality problems and it can not be used normally, our company will get you free of charge to exchange.
5. Precautions
1) The implants can not be reused and not be used with other different brands of implants. The implants were used in a certain limited conditions, and do pay more attention to the clinical use. On the other side, the patients themselves have an affect to the performance of implants as the same.
2), Clinicians should have maxillo-facial surgery or brain surgery clinical experience.
3) Based on patients’ X--film, the type and quantity of the internal fixation titanium plates and the detail circumstances of the patients should be checked, and then decided the suitable operation methods in order to strengthen the stability of fixation.
4) If damaged the implants products, their intensity will be significantly lower, which may lead to the operation failure.
5) After rehabilitation, give a correct guidance to avoid the implants rupturing,
6) Fixed three or four months after fracture healing, the internal fixation titanium plates and screws became an functionless implants, regarded as foreign matter. As long as out of the implants is not to bring too much suffering, It should be removed, in order to avoid affecting patients wounds muscle.
7) Attention should be paid to packaging, the product should be used in the period of validity, beyond the validity or package damaged, it must be sterilized prior to surgical use.
8) Sterilization approaches:
(a) The titanium plates are first immerged in 3%-5% lysol for half and hour, then washed by distilled water.
(b) The titanium plates are wrapped by degreased gauze and put into the sterilization box.
(c) The box is then disinfected and sterilized in 125 ℃ for half and hour.
9) Implants are disposable, not reuse, removal from the body, they should be destroyed to avoid further using.
10)Surgical tools are not sterilized, just do it by yourself before surgery.
6. Internal Fixation Titanium Plates
1. Summary
1), CB-type internal fixation Titanium plates are carefully made of biologically mutual dissolved and high toughness unalloyed titanium materials, which accord with GB/T13810-97 standard. With the use of internal fixation titanium screws for oral surgery, brain surgery for bone reconstruction and internal fixation. The main types are :
l Maxilla internal fixation titanium plates (thickness of 0.6mm),
l Mandibular internal fixation titanium plates (thickness of 1.0mm)
l Reconstruction internal fixation titanium plates (thickness of 2.0mm),
l Orthognathic surgery internal fixation titanium plates (thickness of 0.8mm)
l Three-dimensional mesh titanium plates for cerebral surgery (thickness of 0.6mm).
2. Registration Number and Standard
1), Registration number: SFDA (Allow) No. 2004-3460445(Amend)
2), Standard: YZB/ National 1645-2005 internal fixation titanium plates
3. Requirements
1), The surgical implants plates are made of unalloyed titanium accord with the GB/T13810-97 standard, the material code is A.
2). The surface of the plates shouldn’t have microcrack.
3), The roughness of the hole and grooves surface is less than or equal to 3.2 um; the roughness of the internal surface is less than or equal to 1.6um; the roughness of the external surface is less than or equal to 0.8 um.
4) The surface of the plates should be smooth, without any edges, scratches,burrs,nicks ,deformations ,matter adhesive and other defects.
5) The depth of the hole drilled must be fixed with titanium screws.
4. Specifications
Different plates have different thickness (see page summary), also different shape to fit for the clinical treatment. The patterns of the plates as follows:
l CBZI for straight and I-like plates ;
l CBYL for strange shape and L-like plates;
l CBYX for strange shape and X-like plates;
l CBYY for strange shape and Y-like plates;
l CBYT for strange shape and T-like plates;
l CBYV for strange shape and V-like plates;
l CBZI0.6- □×□ for three-dimensional mesh plates;
See products shows on our website for more details.
7. Internal Fixation Titanium Screws
1. Summary
CB-type internal fixation Titanium screws are carefully made of biologically mutual dissolved and high toughness Ti-6Al-4V titanium alloys materials, with the use of internal fixation titanium screws for the fixation of oral and maxillofacial surgery and cranial surgery. The main types are:
l Internal fixation screws
l Self-Drilling Microscrew Anchorage
l Intermaxillary traction (IMT) titanium screws
l Lag titanium screws
2. Registration Number and Standards
1), Registration number: SFDA(Allow)No: 2004 -3460446 (Amend)
2), Standard: YZB/ National 1646-2005 internal fixation titanium screws
3. Requirements
1) The surgical implants screws are made of Ti-6Al-4V Titanium alloys, which accord with the GB/T13810-97 standard, and the material code is T.
2). The surface of the plates shouldn’t have microcrack.
3), The roughness of the surface of the screws head is less than or equal to 0.4um; the roughness of the surface of the screw thread is less than or equal to 3.2um; the roughness of the other parts is less than or equal to 1.6 um.
4) The surface of the screws should be smooth, no-edges, without any matters adhesive; also there shouldn’t have dents and sharp-edges (except for blade) on the screw thread.
5) Fixed the screws tight
4. Specifications
The length of the screws lied on the treatment part. According to the different clinical targets, the internal fixation screws also can be classified as follows:
l Internal fixation screws
l Self-Drilling Microscrew Anchorage
l Intermaxillary traction (IMT) titanium screws
l Lag titanium screws
See products on our website for more details.
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